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First-line modified FOLFOX plus/minus nivolumab and Ipilimumab or FLOT plus nivolumab in advanced gastroesophageal adenocarcinoma: a phase II multi-cohort trial

This multi-cohort study evaluates whether dual immune checkpoint inhibition with nivolumab and ipilimumab in parallel or sequentially, or triplet chemotherapy with nivolumab can enhance efficacy as first-line therapy for advanced or metastatic gastroesophageal adenocarcinoma. Patients are randomized...

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Main Authors: Lorenzen, Sylvie (Author) , Goetze, Thorsten Oliver (Author) , Thuss-Patience, Peter C. (Author) , Riera-Knorrenschild, Jorge (Author) , Goekkurt, Eray (Author) , Dechow, Tobias Nicolaas (Author) , Ettrich, Thomas Jens (Author) , Hofheinz, Ralf-Dieter (Author) , Luley, Kim Barbara (Author) , Pink, Daniel (Author) , Lindig, Udo (Author) , Folprecht, Gunnar (Author) , Schuch, Gunter (Author) , Bitzer, Michael (Author) , Heinemann, Volker (Author) , Angermeier, Stefan (Author) , Bolling, Claus (Author) , Loose, Maria (Author) , Junge, Sabine (Author) , Pauligk, Claudia (Author) , Al-Batran, Salah-Eddin (Author)
Format: Article (Journal)
Language:English
Published: 27 February 2026
In: Nature Communications
Year: 2026, Volume: 17, Pages: 1-9
ISSN:2041-1723
DOI:10.1038/s41467-026-69622-7
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1038/s41467-026-69622-7
Verlag, kostenfrei, Volltext: https://www.nature.com/articles/s41467-026-69622-7
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Author Notes:Sylvie Lorenzen, Thorsten Oliver Goetze, Peter C. Thuss-Patience, Jorge Riera-Knorrenschild, Eray Goekkurt, Tobias Nicolaas Dechow, Thomas Jens Ettrich, Ralf Dieter Hofheinz, Kim Barbara Luley, Daniel Pink, Udo Lindig, Gunnar Folprecht, Gunter Schuch, Michael Bitzer, Volker Heinemann, Stefan Angermeier, Claus Bolling, Maria Loose, Sabine Junge, Claudia Pauligk & Salah-Eddin Al-Batran
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Summary:This multi-cohort study evaluates whether dual immune checkpoint inhibition with nivolumab and ipilimumab in parallel or sequentially, or triplet chemotherapy with nivolumab can enhance efficacy as first-line therapy for advanced or metastatic gastroesophageal adenocarcinoma. Patients are randomized 1:1 to Arm A (mFOLFOX + nivolumab 240 mg every two weeks + ipilimumab 1 mg/kg every six weeks in parallel or Arm B (mFOLFOX). Subsequently, patients are randomized 1:2 to Arm A1 (identical to Arm A) or Arm A2 (three cycles of mFOLFOX followed by nivolumab + ipilimumab). In Arm C all patients receive FLOT + nivolumab. Primary endpoint is progression-free survival. Secondary endpoints include overall survival and objective response rate. Median progression-free survival (months) is: Arm A/A1, 5.8; Arm A2, 4.0; Arm B, 6.6 and Arm C, 7.0.Toxicity is manageable across all arms, with higher rates in arms receiving dual checkpoint inhibition. Here we show that chemotherapy with dual checkpoint inhibition in parallel increases toxicity without improving efficacy, while FOLFOX followed by immunotherapy is insufficient. FLOT with nivolumab appears feasible and shows promising efficacy. ClinicalTrials.gov number NCT03647969
Item Description:Gesehen am 23.03.2026
Physical Description:Online Resource
ISSN:2041-1723
DOI:10.1038/s41467-026-69622-7

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